(261 days)
Yes
The device description explicitly mentions "Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together" and "uAI Vision patient positioning assistance function based on deep learning technology". It also lists several other features based on deep learning and deep neural networks.
No
This device is a diagnostic imaging system (CT scanner) used to produce cross-sectional images for diagnostic purposes, such as detecting lung nodules, rather than to treat a condition.
Yes
The device is described as an x-ray computed tomography system intended to produce cross-sectional images of the whole body. It is explicitly stated that the device is "intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer," and that it is "designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality." These statements clearly indicate its use in diagnosing medical conditions.
No
The device description explicitly states that the proposed device includes "image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories," and details hardware specifications like detector size, rotation speed, and bore size.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The uCT ATLAS is a computed tomography x-ray system. It produces images of the inside of the body using x-rays. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) diagnostic test.
- Intended Use: The intended use describes the device's purpose as producing cross-sectional images of the whole body for diagnostic purposes. It does not mention analyzing samples taken from the body.
- Device Description: The description focuses on the hardware and software used for image acquisition, reconstruction, and analysis of the x-ray data obtained from the patient's body.
Therefore, the uCT ATLAS is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.
uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
u WS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
Product codes
JAK
Device Description
The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.
The uCT ATLAS is a multi-slice computed tomography scanner that features the following specification and technologies.
-
160 mm z-coverage in a single axial exposure with a 320-row 0.5 mm-slice Z-Detector
-
. 0.25 s rotation speed for high temporal resolution, and maximum 440 mm/s fast volumetric scanning capability
-
. 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible positioning and access for all patients
-
. The new generation reconstruction method. Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time
improving low contrast detectability and spatial resolution -
. The uAI Vision patient positioning assistance
Built upon these technologies, the uCT ATLAS is designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality. Further, the whole organ coverage and fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.
The uWS-CT-Dual Energy Analysis is a software package that uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography x-ray
Anatomical Site
Whole body, head, heart, liver, kidney, pancreas, joints, vascular. Low dose CT lung cancer screening for lung nodules.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing including dosimetry and image performance tests were conducted for the uCT ATLAS with uWS-CT Dual Energy Analysis during the product development.
Performance Evaluation Report for the functions.
Clinical Image Evaluation of applications.
Software Verification and Validation testing showed that all software specifications met acceptance criteria.
No Clinical Study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K161009, K193073, K132813, K120833
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
August 11, 2021
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Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao RA Manager No. 2258 Chengei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA
Re: K203448
Trade/Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: July 12, 2021 Received: July 15, 2021
Dear Xin Gao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
. for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203448
Device Name
uCT ATLAS with uWS-CT-Dual Energy Analysis
Indications for Use (Describe)
uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.
uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
u WS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and modern in design.
510 (K) SUMMARY
K203448
-
- Date of Preparation November 18, 2020
Sponsor Identification 2.
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin GAO Position: RA Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Device Name: uCT ATLAS with uWS-CT-Dual Energy Analysis Common Name: Computed Tomography X-ray System Model(s): uCT ATLAS
Regulatory Information
Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
4. Identification of Predicate/Reference Device(s)
Predicate Device
510(k) Number: K172135 Device Name: uCT 760, uCT 780 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
Reference Device #1
510(k) Number: K161009 Device Name: Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray and has a white vertical line running through the center, creating a negative space effect.
Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK
Reference Device #2
510(k) Number: K193073 Device Name: Deep Recon Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK
Reference Device #3
510(k) Number: K132813 Device Name: DUAL ENERGY SYSTEM PACKAGE Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK
Reference Device #4
510(k) Number: K120833 Device Name: DISCOVERY CT750 HD Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK
ട്. Device Description:
The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.
The uCT ATLAS is a multi-slice computed tomography scanner that features the following specification and technologies.
- 160 mm z-coverage in a single axial exposure with a 320-row 0.5 mm-slice Z-• Detector
- . 0.25 s rotation speed for high temporal resolution, and maximum 440 mm/s fast volumetric scanning capability
- . 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible positioning and access for all patients
- . The new generation reconstruction method. Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time
5
Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The logo is simple and modern, and the colors are muted.
improving low contrast detectability and spatial resolution
- . The uAI Vision patient positioning assistance
Built upon these technologies, the uCT ATLAS is designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality. Further, the whole organ coverage and fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.
The uWS-CT-Dual Energy Analysis is a software package that uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information.
6. Indications for Use
The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes a CT System and a software package.
uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.
uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical societv.
- Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is also in bold. The color of the text and the "U" shape is a dark teal.
Analysis software combines images acquired with low and high energy spectra to visualize this information.
7. Comparison of Technological Characteristics with the Predicate/Reference Devices
The uCT ATLAS with uWS-CT-Dual Energy Analysis has the same intended use as the predicate device uCT 760, uCT 780.
The proposed device includes more technology/features, which is discussed in the following chapters, than the predicate device. These differences will not impact the safety and effectiveness of the device.
| ITEM | Proposed Device | Predicate Device
uCT 760, uCT 780
(K172135) | Remark |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Specifications | | | |
| Gantry | ●
160mm Detector
Rotation speed:
up to
0.25s/rotation
●
82cm bore | ●
40mm Detector
Rotation speed: up
to 0.35s/rotation
(uCT 760); up to
0.3s/rotation (uCT
780)
●
70cm bore | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| Patient Table | Max. load capacity
318kg | Max. load capacity 205kg | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| Reconstruction Field
of View | 40mm-500mm
40mm-600mm with
extend FOV | 40mm-500mm | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| Maximum slices
generated per
rotation | 640 | uCT 760:128
uCT 780:160 | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| Functions | | | |
| Low Dose CT Lung
Cancer Screening
Protocol | Yes | -- | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| uAI Vision -
EasyPositioning
EasyISO | Yes, | -- | Substantially Equivalent |
| | It's a patient
positioning assistance
function based on deep
learning technology | -- | The changes did not raise new
safety and effectiveness
concerns. |
| Auto ALARA kVp | Yes
It can recommend the
suitable kVp for the
examination. | -- | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| Organ-Based Auto
ALARA mA | Yes
It can optimize the
dose modulation for
the combined chest
and abdomen scan
with deep learning
based organ
recognition. | -- | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| CardioXphase | Yes
It can recommend the
optimal phase for
cardiac reconstruction
with less motion
artifact. | -- | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| CardioCapture | Yes
It can reduce the
coronary motion
artifact with deep
learning based
coronary artery
extraction. | -- | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| EasyRange | Yes
It can automatically
recommend the scan
range with a deep
learning organ
recognition
technology | -- | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| Injector Linkage | Yes | -- | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
| Remote Assistance | Yes | -- | Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns. |
Table 1 Comparisons to Predicate Device
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal.
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue and has a white vertical line running through the center. The logo is simple and modern in design.
| Item | Proposed device | Reference device #1
Aquilion ONE Vision
With FIRST 2.0
(CCRS-001B) V7.4
(K161009) | Reference device #2
Deep Recon
(K193073) | Discussion of
differences |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Anatomical
Region | Abdomen, pelvis,
chest | Abdomen, pelvis,
chest, cardiac and
extremities | Abdomen, pelvis,
chest, cardiac and
head | Same |
| Exposure Dose
Reduction | Yes | Yes | Yes | Same |
| Quantitative
Dose Reduction
Claim | Yes | Yes | Yes | Same |
| Image Quality
Improvement
Claim | Yes | Yes | Yes | Same |
| Reconstruction
Technology | It is an image
reconstruction
method that
combines a
modal-based
iterative
reconstruction
and deep learning
technology. | It is an iterative
reconstruction
algorithm. | Dedicated deep neural
network (DNN) which
is trained on low dose
FBP images to get
normal dose (high
quality) FBP images | Substantially
Equivalent
Testing did not
raise new safety
and effectiveness
concerns. |
Table 3 Dual Energy comparison to Reference Devices
| Item | Proposed
Device | Reference device #3
Dual Energy System
Package (K132813) | Reference device #4
Discovery CT750 HD
(K120833) | Discussion of
differences |
|-----------------------------------------|--------------------|----------------------------------------------------------------|--------------------------------------------------------|------------------------------|
| Dual Energy Scan | Yes | Yes | Yes | Same |
| Dual Energy Analysis | | | | |
| Mono Energetic Image | Yes | Yes | -- | Same |
| Mixed Enhanced Image | Yes | Yes | -- | Same |
| CNR(Contrast Noise Ratio)
Image | Yes | Yes | -- | Same |
| Water-Iodine Base Material
Pair | Yes | -- | Yes | Same |
| Water-Calcium Base
Material Pair | Yes | -- | Yes | Same |
| Calcium-Iodine Base
Material Pair | Yes | -- | Yes | Same |
| Uric acid-Calcium Base
Material Pair | Yes | -- | Yes | Same |
| Image Registration | Yes | Yes | -- | Same |
| Effective Atomic Number
Images | Yes | -- | Yes | Same |
| Electron Density Image | Yes | -- | Yes | Same |
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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray. The logo is simple and modern in design.
| Virtual Non contrast Images | Yes | -- | Yes | Same |
|---|---|---|---|---|
| Component analysis of | ||||
| kidney stones, uric acid | ||||
| stones or non-uric acid | ||||
| stones | Yes | Yes | -- | Same |
| Component analysis of joint | ||||
| gout, uric acid gout or non- | ||||
| uric acid gout | Yes | Yes | -- | Same |
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Testing
Non-clinical testing including dosimetry and image performance tests were conducted for the uCT ATLAS with uWS-CT Dual Energy Analysis during the product development.
UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uCT 760/780 in accordance with the following standards:
- A ES 60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- A IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
-
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and testsIEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008). Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
Product Particular Standards
- NEMA XR 25-2019, Computed Tomography Dose Check A
- A NEMA XR 28-2018, Supplemental Requirements For User Information And System Function Related To Dose In CT
-
NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
-
IEC 60601-1-3 Edition 2.1 2013-04, Medical Electrical Equipment - Part 1-3:
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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark gray with a white vertical line running through the center.
General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-ray Equipment
- A IEC 61223-3-5 First Edition 2004-08, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment [Including: Technical Corrigendum 1 (2006)]
Performance Verification
- A Performance Evaluation Report for the functions
- A Clinical Image Evaluation of applications
Software
- NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine A (DICOM)
- A IEC 62304: Medical Device Software - software life cycle process
-
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Biocompatibility
- ISO 10993-5 Third Edition 2009-06-01. Biological Evaluation Of Medical > Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
Other Standards and Guidances
- A ISO 14971: Medical Devices - Application of risk management to medical devices
- Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
-
Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
- A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
-
Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
Software Verification and Validation
Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.
The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have
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met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.
UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.
Clinical Testing
No Clinical Study is included in this submission.
Summarv
The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT ATLAS with uWS-CT Dual Energy Analysis was found to have a safety and effectiveness profile that is similar to the predicate device.
9. Conclusions
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety, and effetiveness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety, and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.